Getinge Disinfection AB

Address:LJUNGADALSGATAN 11,VAXJO Kronoberg,SE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Disinfector, Medical Devices (MEC) (10)

Premarket Exempt

Yes

Clear

GETINGE CM320-SERIES - 07340153700215 Catalog Number : CM320WWWD

Device Description : CM320-4 CHAMBER WWWD. Washer disinfector with four chambers; Three washer chambe CM320-4 CHAMBER WWWD. Washer disinfector with four chambers; Three washer chambers followed by a dryer chamber.

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE WD 14 TABLO - 07340153700222 Catalog Number : GE14-003

Device Description : GETINGE WD14 TABLO, WASHER DISINFECTOR

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE WD 15 CLARO - 07340153700239 Catalog Number : GE15-003

Device Description : GETINGE WD 15 CLARO, WASHER DISINFECTOR

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 86-SERIES - 07340153700246 Catalog Number : S-86662001

Device Description : WASHER DISINFECTORCatalog number was S-86661001.Catalog number updated to S-8666 WASHER DISINFECTORCatalog number was S-86661001.Catalog number updated to S-86662001 in November 2018.

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 86-SERIES - 07340153700253 Catalog Number : S-86662003

Device Description : WASHER DISINFECTORCat.No updated from S-86662001 to S-86662003

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 86-SERIES - 07340153700260 Catalog Number : S-86682001

Device Description : WASHER DISINFECTORCatalog number was S-86681001.Catalog number updated to S-8668 WASHER DISINFECTORCatalog number was S-86681001.Catalog number updated to S-86682001 in November 2018.

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 86-SERIES - 07340153700277 Catalog Number : S-86682003

Device Description : WASHER DISINFECTORCat. No. updated from S-86681003 to S-86682003

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 9100-SERIES - 07340153710023 Catalog Number : 9120E-001

Device Description : WASHER DISINFECTOR 9120E

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 9100-SERIES - 07340153710030 Catalog Number : 9122EW-001

Device Description : WASHER DISINFECTOR 9122EW

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 9100-SERIES - 07340153710047 Catalog Number : 9125E-001

Device Description : WASHER DISINFECTOR 9125E

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

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